| 09.00 - 09.30 |
Welcome,
Introduction, Presentation of the Speaker |
| 08.30 - 09.30 |
Regulatory
Requirements of Good Storage Practice
- Europe
- USA
- Legal Responsibilities
|
| 09.30 - 10.30 |
Good Storage
Practice
- Facilities and equipment
- Environmental monitoring
- Product handling
- Maintenance
- GSP
|
| 10.30 - 10.45 |
Break |
| 10.45 - 11.45 |
GMP-based
Documentation
- SOPs
- Maintenance of SOPs
- Documentation of the work
- Monitoring of the storage
conditions
- Computerised systems
|
| 11.45 - 12.45 |
GMP conforming Work
and Behavior
- Maintenance of goods
- Incoming controls
- Quarantine
- Release
|
| 12.45 - 13.45 |
Lunch |
| 13.45 - 14.45 |
Management of
Returned Goods
- Different storage
- Labelling
- Measures necessary
- Links to other department
|
| 14.45 - 15.00 |
Break |
| 15.00 - 16.00 |
GMP Failures and
Warning Letters
|
| 16.00 - 16.30 |
Discussion
|
